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Czech Republic Between Shortage and Shortfall: A Buzz Interview with Milena Hoffmanova of Baker McKenzie

Czech Republic Between Shortage and Shortfall: A Buzz Interview with Milena Hoffmanova of Baker McKenzie

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Emphasizing the urgency of healthcare reforms in the Czech Republic – given acute supply issues and the need to address systemic challenges effectively – Baker McKenzie Partner Milena Hoffmanova underscores the importance of collaborative efforts between stakeholders to ensure sustainable and equitable healthcare delivery in the country.

“The Pharma industry in the Czech Republic is currently implementing one of the biggest changes in the regulation on the distribution of pharmaceuticals in recent years,” Hoffmanova begins. “An amendment entered into effect at the beginning of this year, with the rest to come into play later, bringing legislative changes meant to impact the availability of medicinal products in the country. Due to the Czech Republic’s pricing policies and import-export dynamics, we’ve faced numerous challenges posed by shortages of medicines – a problem and a topic for both the public, pharmacies and pharma businesses, and authorities.”

Hoffmanova explains that the key amendments introduced in January aim to address shortages and improve availability, and include extended supply obligations for marketing authorization holders and stockpiling requirements for distributors. She elaborates: “The amendment brings several new obligations for marketing authorization holders as well as distributors. It mandates that marketing authorization holders must supply medicinal products for an additional one to two months, even after the reported date of interruption or termination of supplies. Additionally, upon the decision of the Ministry of Health, distributors might be required to maintain stockpiles of medicines to ensure availability, a task made difficult by the existing shortages.”

Hoffmanova highlights the complexities of implementing these changes, particularly in cases of production shortages and “the ambiguous obligations regarding non-discrimination against pharmacies.” Despite efforts to enhance availability, she acknowledges the ongoing challenges and the limited leverage the Ministry of Health has in addressing systemic issues, and emphasizes the need for a balanced approach to pricing and supply chain management to mitigate shortages effectively.

For context, Hoffmanova also points out that similar issues are being faced by neighboring countries in Central and Eastern Europe, such as Hungary and Poland, which have implemented comparable legislation. On the whole, she says “the region’s collective response to pharmaceutical supply chain issues is characterized by stricter regulations and increased penalties.”

Shifting focus to the impact on local transactions and healthcare networks, Hoffmanova points to the influence of global pharmaceutical deals on local markets. She highlights “the continued success of pharmacy chains and growth of healthcare provider networks in the Czech Republic, driven by private investments.” However, she underscores that “the shortage of healthcare professionals in critical areas, like psychiatry, is posing challenges to that continued service expansion.”

Regarding patient care, Hoffmanova acknowledges the system’s overall effectiveness but raises concerns about its long-term stability and the affordability of new, expensive treatments. “If treatments that can cost millions of Czech crowns are covered and become more frequent, the system will face a shortfall. So, we’ll either have to allocate significantly more public funds to healthcare, introduce coverage limitations, or require patients to participate more significantly in the costs of their healthcare. However, she notes there is “political reluctance to increase the financial burden on patients, due to past failures and public resistance.”

Czech Republic Knowledge Partner

PRK Partners, one of the leading Central European law firms, has been helping clients achieve their business objectives almost 30 years. Our team of lawyers, based in our Prague, Ostrava, and Bratislava offices, has a unique knowledge of Czech and Slovak law and of the business environment. Our lawyers studied at top law schools in the United States, United Kingdom, Switzerland and elsewhere. They also have experience working for leading international and domestic law firms in a number of jurisdictions. We speak your language, too. Our legal team is fluent in more than 15 languages, including all the key languages of the region.

PRK Partners has one of the most experienced legal teams on the market. We are consistently rated as one of the leading law firms in the region. We have received many significant honours and awards for our work. We represent the interests of international clients operating in the Czech Republic in an efficient way, combining local knowledge with an understanding of their global requirements in a business-friendly approach. We are one of the largest law firms in the Czech Republic and Slovakia. Our specialised teams of lawyers and tax advisors advise major global corporations as well as local companies. We provide comprehensive legal advice drawing on our profound knowledge of local law and markets.

Our legal advice delivers tangible results – as proven by our strong track record. We are the only Czech member firm of Lex Mundi, the world's leading network of independent law firms. As one of the leading law firms in the region, we have received many national and international awards, in some cases several years in a row. Honours include the Chambers Europe Award for Excellence, The Lawyer and Czech and Slovak Law Firm of the Year. Thanks to our close cooperation with leading international law firms and strong local players, we can serve clients in multiple jurisdictions around the globe. Our strong network means that we can meet your needs, wherever you do business.

PRK Partners has been repeatedly voted among the most socially responsible firms in the category of small and mid-sized firms and was awarded the bronze certificate at the annual TOP Responsible Firm of the Year Awards.

Our work is not only “business”: we have participated on a longstanding basis in a wide variety of pro bono projects and supported our partners from the non-profit sector (Kaplicky Centre Endowment Fund, Tereza Maxová Foundation, Czech Donors Forum, etc.).

Firm's website: www.prkpartners.com

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